Endoscope and method of use

ABSTRACT

Medical devices and methods related to endoscopic systems suitable for hysterectomy and other purposes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit of priority to U.S. Provisional PatentApplication No. 62/933,081, filed Nov. 8, 2019, the content of which isincorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

The present invention relates generally to medical devices and methods.More particularly, the present invention is related to endoscopicsystems suitable for hysterectomy and other purposes.

Endoscopic systems of the invention intended for hysterectomy typicallycomprise a base station having an image display, a disposable endoscopecomponent with an image sensor, a re-usable handle component that isconnected to an image processor in base station, and a fluid managementsystem integrated with the base station and handle component. Theendoscope component and the re-useable handle are typically referred toas a hysteroscope.

Of particular interest to the present invention, hysteroscopes and otherendoscopes provide for the introduction of interventional tools througha working channel in the shaft of the scope. The size of the workingchannel of a hysteroscope is limited by the need to introduce at least adistal portion of the shaft through the patient's cervix.

Of further interest to the present invention, hysteroscopes may have ashaft rotatable relative to the handle, and that shaft will often carrya camera and light source that need to be externally connected throughthe handle.

Of still further interest to the present invention, rotatablehysteroscope shafts may also carry fluids through a lumen which has anexternal port fixed in the handle.

For these reasons, it would be desirable to provide improvedhysteroscopes which can accommodate the introduction of comparativelylarge tools though a shaft with a relatively low profile. It would befurther desirable to provide improved hysteroscopes which canaccommodate the connection of cameras, light sources, and the like, onrotatable shafts through stationary handles. It would be still furtherdesirable to provide improved hysteroscopes which can accommodate theflow of fluids through rotatable shafts coupled to stationary handles.At least some of these objectives will be met by the inventionsdescribed hereinbelow. However, the methods and devices described hereinwill include additional benefits as recited by the claims.

Hysteroscopic systems of a type similar to that illustrated herein aredescribed in commonly owned, co-pending application Ser. Nos.15/712,603; 15/836,460; 15/861,474; and Ser. No. 15/975,626, the fulldisclosures of which are incorporated herein by reference.

SUMMARY OF THE INVENTION

In a first aspect of the present invention, a hysteroscope or otherendoscopic system comprises a shaft having an outer shaft diameter, adistal shaft portion, a proximal shaft portion, and a longitudinal axisthere between. A handle is coupled to the proximal portion of the shaft,and an image sensor with a diagonal dimension is carried by the distalportion of the shaft. A channel extends through at least the distalshaft portion and has a channel diameter. A section of the channel inthe distal portion of the shaft is re-configurable between a constrictedshape or geometry and a non-constricted shape or geometry to accommodatea tool introduced there through. Because of the re-configurable natureof the distal portion of the channel, the combined diagonal dimensionand channel diameter may be greater than the outer shaft diameter. Thehandle will typically be detachably coupled to the shaft so that thehandle is reusable and the shaft is disposable, but at least someaspects of the present invention will be found in endoscopes comprisingfixed handle-shaft structures as well.

In certain exemplary embodiments of the endoscopes of the presentinvention, the diagonal dimension will be at least 50% of the outershaft diameter, typically being at least 60%, or greater. In furtherexemplary embodiments, the channel diameter will also be at least 50% ofthe outer shaft diameter, more often being at least 60% of the outershaft diameter, or greater.

In other exemplary embodiments, the endoscopes of the present inventionwill be provided in systems which further comprise a fluid inflow sourcefor providing fluid flow through an inflow channel in the shaft to anoutlet in the distal portion of the shaft. Usually, such systems willfurther comprise a negative pressure source for providing fluid outflowsthrough the outflow channel in the shaft and an opening in the distalshaft portion. Still further, the systems may comprises a controller forcontrolling fluid flows through the inflow and outflow channels and atleast one actuator in the handle for adjusting fluid inflows andoutflows. For example, the controller may be configured with algorithmsfor operating the fluid inflow source and the negative pressure sourceto maintain fluid within a set pressure range in a working space, suchas the uterine cavity.

In a second aspect of the present invention, a hysteroscope or otherendoscope comprises a handle having an interior, an axis, and anelectrical connector fixed to the handle. A shaft is removably orotherwise coupled to the handle and configured to rotate, typicallyreversibly rotate, about a longitudinal axis relative to the handlethrough an arc of about 180° or greater. An electronic image sensor iscarried at a distal end of the shaft, and one or more electrical leadsextend from the image sensor to the electrical connector in the handle.The electrical lead(s) are flexible and configured with a “slack”portion in the interior of the handle to accommodate rotation of theshaft. By “slack,” it is meant that the length of the electrical lead(s)is greater than the distance between the electrical connector and thepoint of attachment of the electrical lead(s) to the shaft so that theshaft may be rotated without over tensioning the electrical lead(s).

In further exemplary embodiments of this endoscope, the slack portionmay be formed as any one of a coil, a spiral, a folded structure, aserpentine structure, or the like. In specific embodiments, one end ofthe slack portion will be coupled to and extend around the axis of therotating shaft assembly, typically being carried on a spool secured tothe shaft assembly. The spool is usually aligned concentric orco-axially with the axis of the shaft so that as the shaft is rotated,the spool may take up or let out the flexible electrical leads asneeded. In specific examples, the electrical leads may comprise the flexcircuits.

In still further exemplary embodiments of these endoscopes, a lightemitter may be carried at the distal end of the shaft and secondelectrical lead(s) may extend from the light emitter to a secondelectrical connector fixed in the handle. The second electrical leadsare configured with a second slack portion to accommodate rotation ofthe shaft. The second shaft portion may also be carried on a secondspool and may comprise a flex circuit.

In still further aspects of this endoscope, a channel may be formed inthe shaft where a portion of the channel is re-configurable between aconstricted shape and a non-constricted shape to accommodateintroduction to a tool through the channel. As with the first endoscopicembodiments described above, the combined diagonal dimension and channeldiameter will typically be greater than an outer shaft diameter. Otherspecific aspects of the re-configurable channel described above withrespect to the earlier embodiment may also be found in the endoscopes ofthe second aspect herein.

In the third aspect of the present invention, an endoscope comprises ahandle and an elongated shaft. The elongated shaft is mounted to rotate,typically reversibly, at least 180° about a longitudinal axis of thehandle. An electronic image sensor is carried near a distal end of theshaft, and electrical leads extend from the image sensor to the handle.The electrical leads are configured to coil and uncoil (spool andunspool) over the shaft as the shaft is rotated in opposite directionsabout the longitudinal axis. In specific embodiments of this thirdendoscope structure, the electrical leads may comprise a flex circuitand at least a portion of the flex circuit may have a cross-sectionalarea that is less than 5% of the cross-sectional area of the shaftassembly.

In a fourth aspect of the present invention, an endoscope comprises ahandle in a elongated shaft mounted to rotate by at least 180° about alongitudinal axis of the handle. A flow channel extends though the shaftassembly to a port in a distal end of the shaft. The flow channel has aproximal channel portion fixed in the handle and a distal channelportion that rotates together with the shaft. A fluid-tight housingintermediate the proximal and distal channel portions is configured toprovide a fluid-tight path through the channel portions within the fullrotational range of the shaft.

In specific aspects of the fourth endoscope of the present invention,the rotating shaft may include an annular flow channel that rotates inthe housing. The endoscope may still further include a second flowchannel extending through the handle and shaft assembly, where thesecond flow channel has a proximal channel portion fixed in the handlecomponent and a distal channel portion that rotates in the shaft as theflow channel rotates in the housing.

The illumination source discussed herein can comprise an incandescentlight, an LED, an illumination source that radiates non-visible light,as well as any light transmitting material (e.g., a fiber) thattransmits light from an illumination source.

The descriptions provided herein are examples of the invention describedherein. It is contemplated that combinations of specific embodiments,specific aspects or combinations of the specific embodiments themselvesare within the scope of this disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

Additional aspects of the invention will become clear from the followingdescription of illustrative embodiments and from the attached drawings,in which:

FIG. 1 illustrates components of a hysteroscopic treatment systemcorresponding to the invention, including a perspective view of anendoscopic viewing system and schematic view of a fluid managementsystem.

FIG. 2 is perspective view of the endoscopic viewing system of FIG. 1showing a single-use disposable endoscope component separated from areusable handle component.

FIG. 3A is perspective view of single-use endoscope component of FIG. 2with the handle shell partially removed to show an interior portion ofthe component.

FIG. 3B is perspective view of endoscope component of FIG. 3A with aflow channel housing removed to show features of a rotating shaftassembly.

FIG. 4 is a perspective view of the endoscopic viewing system of FIG. 1from a different angle illustrating rotation of the rotating shaftassembly.

FIG. 5 is another perspective and sectional view of endoscope componentof FIGS. 3A-3B with a flow channel housing removed to show the centralaxis of the working channel around which the shaft assembly rotates andthe off-center longitudinal axis of the outer sleeve of the endoscopeshaft.

FIG. 6 is in an enlarged perspective view of the endoscopic viewingsystem of FIGS. 1 and 2 showing the finger-actuated control panel in thereusable handle component and the sterile and non-sterile fields of thecomponents.

FIG. 7A is an enlarged perspective view of the distal end of theendoscope shaft showing the working channel with a distal channelportion in a reduced cross-sectional configuration for introduction intoa patient's body.

FIG. 7B is another view of the distal end of the endoscope shaft of FIG.7A showing the distal working channel portion in an expandedcross-sectional configuration when a tool is introduced though theworking channel.

FIG. 8 is another view of the distal end of the endoscope shaft assemblyof FIGS. 7A-7B showing the image sensor housing extending distally fromthe distal surface of the outer sleeve tip.

FIG. 9 is another view of the endoscope handle assembly which carries atleast one accelerometer for image orientation.

FIG. 10 is a de-constructed view of the endoscope working end showing aflex circuit configuration.

FIG. 11 is another view of the endoscope working end of FIG. 10.

FIG. 12A is another view of the endoscope working end of FIG. 11 in anon-articulated configuration.

FIG. 12B is another view of the endoscope working end of FIG. 112A in anarticulated configuration.

FIG. 13 is an exploded view of the components of the endoscope workingend of FIGS. 11, 12A and 12B.

FIG. 14 is perspective view of a housing and lens assembly in the distalend of an endoscope similar to that of FIGS. 10, 11, 12A and 12B showinga single flex circuit with multiple bends or folds therein for couplingelectrical leads to the image sensor and to two LEDs.

FIG. 15 is perspective view of the distal portion of the flex circuitFIG. 14 is an exploded view showing the insulator layers in a conductivelayers of the flex circuit in a plane are form showing the multipleleads that connect to the image sensor and the LEDs.

FIG. 16 is perspective view of the proximal portion of the flex circuitFIG. 15 showing the electrical leads that couple to the circuit board inthe endoscope handle.

FIG. 17A is perspective view of the distal portion of the flex circuitFIG. 15 after a first folding step where segments of the flex circuitfolded after coupling to the LEDs to orient light emission from the LEDsin a selected direction.

FIG. 17B is perspective view of the distal portion of the flex circuitFIG. 17A after a second folding step where a portion of the flex circuitis folded orient the image sensor field of view in the distal directionrelative to the shaft of the endoscope.

FIG. 18A is a view of an endoscopic video image on a video display.

FIG. 18B is a view of the endoscopic video image on the video display ofFIG. 18A showing a warning indicator in the form of a colored annularring around the image.

FIG. 19A is a view of an endoscopic video image as in FIG. 18A.

FIG. 19B is a view of the endoscopic video image on the video display ofFIG. 19A showing an annular warning indicator having a first width.

FIG. 19C is a view of the endoscopic video image and annular warningindicator of FIG. 19B having a second width around the image.

FIG. 20A is a view of an endoscopic video image as in FIG. 18A

FIG. 20B is a view of the endoscopic video image of FIG. 20A showing anwarning indicator in the form of a partly annular ring around the image.

FIG. 20C is a view of the endoscopic video image and partly annular ringrotating around the image.

FIG. 21 is a view of the endoscopic video image in the central portionof a video display and a background portion surrounding the image,wherein each of the central and background or peripheral portion have acertain number of pixels associated therewith.

FIG. 22 is a perspective view of a resection probe of the invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a hysteroscopic treatment system 50 corresponding tothe invention which comprises multiple components including anendoscopic viewing system 100 and a fluid management system 105 housedin a base unit or console 108. The base unit 108 also carries acontroller 110A and power source for operating the system 50 and caninclude an image processor 110B for processing signals from an imagesensor carried by the endoscopic viewing system. A display 112 can becoupled to the base unit 108 for viewing images provided by theendoscopic viewing system 100.

More in particular, the endoscopic viewing system 100 of FIGS. 1 and 2includes a re-usable handle component 120 with a finger-actuated controlpad 122 and a disposable single-use endoscope component 125 with anelongated endoscope shaft 126 that carries a distal electronic imagingsensor 128 (see FIGS. 1 and 7A). The fluid management system 105includes a first peristaltic inflow pump 140A and second peristalticoutflow pump 140B, a fluid source 142 and fluid collection reservoir 144which can include a fluid deficit measurement subsystem as is known inthe art. Each of the systems and subsystems will be described in moredetail below.

Referring to FIGS. 1, 2 and 3B, it can be seen that the endoscopicviewing system 100 includes a handle component 120 and a detachablesingle-use endoscope component 125. In FIG. 2, the single-use endoscopecomponent 125 can be seen as an assembly of a proximal handle housing145 which carries a rotating shaft assembly 150 that is configured torotate the handle housing 145.

Referring to FIGS. 1, 3B and 5, the rotating shaft assembly 150 includesa proximal cylindrical grip 152 that is coupled to a molded rotatingcore 155 that in turn is coupled to elongated outer sleeve 160 thatextends to the distal working end 162 the endoscope component 125 (FIG.1). The rotating shaft assembly 150 rotates around a rotational axis165. A working channel 170 extends about axis 165 through the rotatingshaft assembly 150 from a proximal port 172 (see FIGS. 2 and 6). Theworking channel sleeve 174 that carries the working channel 170 can beseen in FIGS. 3A, 3B and 5. Thus, the shaft assembly 150 rotates aboutthe central longitudinal axis 165 of the working channel 170. As can beseen in FIGS. 5 and 7A, the outer sleeve 160 has a central longitudinalaxis 175 that is offset from the longitudinal axis 165 around which theshaft assembly 150 rotates. FIG. 4 shows that the grip 152 has a visualmarker 178 that is aligned with the offset distal tip section 185 toallow the operator to know the orientation of the image sensor 128 byobservation of the grip 152.

In FIGS. 1, 4, 6 and 7A, it can be seen that the endoscope shaft 126 andmore particularly the outer sleeve 160 extends in a straight proximalsleeve portion 180 to an offset distal tip section 185 with an axis 182that is also from 2 to 10 mm offset from the central axis 175 of theouter sleeve 160 (FIG. 7A). The outer sleeve 160 has a transitionsection 186 that extends at an angle ranging between 10° and 45° over alength of 5 to 20 mm between the straight proximal sleeve section 180and the offset distal tip section 185. The imaging sensor 128 isdisposed at the distal end of the offset tip section 185 (see FIG. 7A).As can be seen in FIGS. 5 and 7B, the endoscope component 125 and morein particular the working channel 170 is adapted to receive an elongatetool 188 that can be introduced through the working channel 170. In onevariation, the elongated outer sleeve 160 in each of the straight,transition and distal tip sections (180, 186 and 185, respectively) hasa diameter ranging between 4 mm and 10 mm with an overall lengthconfigured for use in hysteroscopy. More commonly, the diameter ofendoscope shaft 126 is from 5 mm to 6 mm in diameter. It has been foundthat the endoscope shaft 126 with the angled transition section 186 andoffset distal tip section 185 can be introduced through a patient'scervical canal without dilation beyond the dilation necessary for theprofile or diameter SD of the straight proximal sleeve section 180. Inother words, the tissue around the patient's cervical canal conforms tothe angles in the endoscope shaft 126 as the shaft is being advancedthrough the cervical canal.

In one variation, the handle housing 145 of endoscope component 125 isadapted for sliding, detachable engagement with the handle component 120as can be best seen in FIGS. 2 and 4. As can be easily understood, whenassembled, the operator can grip the pistol grip handle component 120with one hand and rotate the cylindrical rotating grip 152 with thefingers of the other hand to rotate the endoscope shaft and image sensor128 to orient the viewing angle of the image sensor 128 and a tool 188to any desired rotational angle. As will be described below, therotating shaft assembly 150 can be rotated at least 180° and more oftenat least 270° (FIGS. 3B and 5). In one variation, the shaft assembly 150can be rotated 360° so as to orient the image sensor 128 in anysuperior, lateral or downward direction relative to the handle housing145.

As can be seen in FIG. 2, the handle housing 145 carries a projectingelectrical connector 190A that is adapted to couple to a matingelectrical connector 190B in the handle component 120. While FIG. 2illustrates that the endoscope component 125 is configured for axialsliding engagement with the handle component 120, it should beappreciated that the angled pistol grip portion 192 of the handlecomponent 120 could plug into the endoscope component 125 in a differentarrangement, such as a male-female plug connector or a threadedconnector aligned with the axis 194 of the angled grip portion 192. Aswill be described below, the endoscope component 125 comprises a steriledevice for use in the sterile field, while the handle component 120 maynot be sterilized and is typically adapted for use for use in anon-sterile field. A cable 195 extends from the handle component 120 tothe base unit 108, imaging processor 110B and controller 110A whichincludes a power source (see FIG. 1).

As can be seen in FIGS. 1 and 2, the endoscope component 125 includesfluid inflow tubing 200A and fluid outflow tubing 200B that communicatewith the fluid management system 105 which is shown schematically inFIG. 1. As can be understood from FIGS. 2, 3A and 3B, the endoscopehandle housing 145 can consist of two injection molded plastic shellelements, 204 a and 204 b (see FIG. 4), and FIG. 3A shows one shellelement 204 a removed to show the interior of the handle housing 145. Itcan be seen that both the inflow tubing 200A and outflow tubing 200B arecoupled to an injection molded flow channel housing 205 with an interiorbore 208 that is configured to receive a rotating core 155 of therotating shaft assembly 150.

FIG. 3B is another view similar to that of FIG. 3A with the second shellelement 204 b removed and the flow channel housing 205 also removed(phantom view) to illustrate how the stationary inflow and outflowtubing, 200A and 200B, communicate with the inflow and outflow pathwaysin the rotating shaft assembly 150 which rotates at least 180°.

Referring to FIGS. 3A and 3B, it can be seen that the rotating core 155is centrally aligned with the axis 165 of working channel 170 and isfurther coupled to the off-center elongated outer sleeve 160 of theendoscope shaft 126. The proximal end 212 of the rotating core 155 isfixed to the grip 152 for rotating the rotating core 155 in the flowchannel housing 205.

The rotating core 155 includes first, second and third flanges 218 a,218 b and 218 c which define annular flow channels 220 and 222therebetween. It can be seen that annular channel 220 is disposedbetween the first and second flanges 218 a and 218 b. Annular channel222 is disposed between the second and third flanges 218 b and 218 c.Each of the first, second and third flanges 218 a, 218 b and 218 c carryan outer O-ring 224 a, 224 b and 224 c. From the views of FIGS. 3A and3B, it can be understood how the rotating flanges 218 a-218 c rotate inthe bore 208 of the flow channel housing 205 and the O-rings 224 a-224 cmaintain a fluid tight seal between the annular flow channels 220 and222.

Again referring FIGS. 3A and 3B, it can be seen that the distal end 230a of inflow tubing 200A is fixed in the flow channel housing 205 tocommunicate with annular flow channel 222. Similarly, the distal end 230b of outflow tubing 200B is fixed in the flow channel housing 205 tocommunicate with annular flow channel 220. Thus, each of the annularflow channels 222 and 220 can rotate up to 360° and communicate with thestationary distal ends of the inflow tubing 200A and outflow tubing200B.

FIG. 3B further shows how the annular flow channels 222 in 220communicate with separate flow pathways that extend through the interiorof the elongated sleeve 160 to the working end 162 of the endoscopeshaft 126. The fluid inflow pathway can be seen in FIG. 3B which extendsthrough annular gaps AG around the exterior of inner sleeve portion 235of the rotating core 155 within the second annular channel 222. Suchannular gaps AG extend distally to communicate with the interior bore242 of the outer sleeve 160. In one variation, the pathway within saidinterior bore 242 transitions to the inflow sleeve 244 with distaloutlet 245 as shown in FIGS. 7A-7B.

The fluid outflow pathway also can be seen in FIG. 3B wherein an opening250 is provided in the inner surface of annular space 220 of therotating core 155 which communicates with the interior working channel170. Thus, the outflow pathway from a working space in one variationcomprises the working channel 170 which is fully open for fluid outflowswhen there is no tool 188 in the working channel. In FIG. 5, it can beseen that a tool seal 252 is shown in the proximal region of the workingchannel 170 that seals the channel 170 and also permits the tool 188 tobe introduced therethrough. Many types of seals are known such in theart as silicone sleeve seals, flap seals and the like. Typically, when atool is introduced through the working channel 170, the tool itself willprovide an outflow channel. Thus, the use of the working channel 170 asoutflow passageway is adapted for diagnostic procedures when using theendoscope without a tool in the working channel.

In a method of use, the endoscope shaft 126 can be navigated through apatient's end cervical canal with the inflow and outflow pumps 140A and140B (see FIG. 1) operating to provide continuous irrigation through thedistal tip section 185 of the endoscope component 125 together withendoscopic viewing by means of image sensor 128. Such a variation willthus allow fluid inflows through annular channel 222 and fluid outflowsthrough the working channel 170 and annular channel 220.

Now turning to FIGS. 7A-7B, the endoscope shaft 126 has a smallinsertion profile or configuration that consists of the outer diameterof the elongated outer sleeve 160 which includes the proximal straightsection 180, the angled transition section 186 and the distal tipsection 185 (FIG. 7A). It can be seen in FIG. 7A that the distal tipsection 185 carries an image sensor 128 and two LEDs 260 which requirean electrical connection to base unit 108, the controller 110A andimaging processor 110B. In order to provide the large number ofelectrical leads required for the image sensor 128, it was found thatconventional multi-wire electrical cables were too large to beaccommodated by the small diameter outer sleeve 160 which alsoaccommodates working channel 170, an inflow channel 244 and potentiallyother fluid flow channels. For this reason, it was found that a printedflex circuit in the form of a flat ribbon 265 (FIG. 5) could providefrom 10 to 40 electrical leads and occupy only a thin planar spacewithin the endoscope shaft 126. FIG. 7A shows the flex circuit ribbon265 extending from the image sensor 128 proximally within outer sleeve160. In one variation shown in FIGS. 3A, 3B, 5 and 7A, a second flexcircuit ribbon 270 is provided to power the LEDs 260. In anothervariation, the first flex circuit ribbon 265 could potentially carryelectrical leads to the image sensor 128 and to the two LEDs 260.

Now turning to FIGS. 3A, 3B and 5, mechanisms are illustrated thatprovide for needed slack in the electrical circuitry or flex circuitribbons 265 and 270 for accommodating rotation of the rotating shaftassembly 150 relative to the handle housing 145 (FIG. 3A). As can bestbe seen in FIGS. 3B and 5, the rotating shaft assembly 150 includes afirst or distal spool 280 around which the flex circuit ribbon 265 canbe coiled or spooled. The distal spool 280 is formed as a part of therotating core 155 of the rotating shaft assembly 150. Any suitablelength of the flex circuit ribbon 265 can be provided as needed to allowfor at least 180° rotation, or more often, 360° of rotation of therotating shaft assembly 150 relative to the handle housing 145. In thevariation shown in FIGS. 3B and 5, it can be seen that a second orproximal spool 285 comprises a portion of the rotating core 155 and isadapted for receiving a slack length of the second flex circuit ribbon270 that extends to the two LEDs 260. In FIGS. 3B and 5, it can be seenthat the proximal ends 265′, 270′ of the flex circuit ribbons 265, 270are coupled to electrical connector 190A by plug connector 288 a and 288b. While the variation of FIGS. 3A-3B shows the endoscope handleaccommodating the flex circuit ribbon 265 in a spool 280, it should beappreciated that the slack portion of the flex circuit ribbon can beconfigured with at least one of a coiled form, spiral form or foldedform without a spool.

In one aspect of the invention, referring to FIG. 7A, an endoscope shaft126 is provided that carries a distal image sensor 128 wherein thediameter of a working channel 170 in the shaft 126 is greater than 50%of the outer diameter of the shaft 126 and the electrical leads to theimage sensor 128 comprise the flex circuit 265. In such a variation, theflex circuit ribbon has a thickness of less than 0.4 mm and a width ofless than 5.0 mm. More often, the flex circuit ribbon has a thickness ofless than 0.3 mm and a width of less than 4.0 mm. Further, in thisvariation, the flex circuit ribbon carries at least 10 electrical leadsof often more than 15 electrical leads. In another aspect, electricalleads extending to the image sensor 128 are in a cable or ribbon thathas a cross-section that is less than 5% or the cross-section of theendoscope shaft 126. In another aspect of the invention, the endoscopecomprises a shaft carrying a distal image sensor, a working channelextending through the shaft wherein the working channel in a distalshaft portion is re-configurable between a constricted shape and anon-constricted shape to accommodate a tool introduced therethrough,wherein the combined diagonal dimension DD of the sensor and thediameter WCD of the working channel 170 is greater than the shaftdiameter SD in its insertion configuration or profile (see FIGS. 4, 6and 7A).

In a specific example, the image sensor 128 is available fromOmniVision, 4275 Burton Drive, Santa Clara, Calif. 95054 with the partname/number: High Definition Sensor OV9734 with a 1280×720 pixel count.The sensor 128 has package dimensions of 2532 μm×1722 μm, with adiagonal DD of 3062 μm or 3 mm. Further, the proximal shaft (outer)diameter SD is 5 mm with the working channel diameter WCD being 3 mm.Thus, the combined sensor diagonal DD (3 mm) and the working channeldiameter WCD (3 mm) equals 6 mm which is greater than the outer shaftdiameter of 5 mm. In this example, the flex circuit ribbon is 3.4 mm inwidth and 0.2 mm thickness with a cross-sectional area of 0.68 mm² whichis 3.52% of the 5 mm diameter shaft having a cross-sectional area of19.63 mm². In this specific variation, the flex circuit ribbon 265carries 19 electrical leads.

Referring again to FIGS. 7A-7B, the distal portion of the endoscopeshaft 126 includes a distal working channel portion 170′ that isre-configurable between a first smaller cross-section as shown in FIG.7A for accommodating fluid outflows and a second larger cross-section asshown in FIG. 7B for accommodating a tool 188 introduced through theworking channel 170 and its distal portion 170′.

In one variation as shown in FIGS. 3A-3B, 5, 6, and 7A, it can be seenthat the working channel sleeve 174 that defines working channel 170extends in a straight configuration through the endoscope component 125from its proximal opening port 172 to its open distal termination 290.As can be seen in FIGS. 7A and 7B, the distal end 292 of sleeve 174 hasa superior surface 294 that is straight and rigid. The working channelsleeve 174 has an inferior or lower sleeve portion 296 that is flexibleand in one variation has a living hinge portion 298 below sidewallcut-outs 302 a and 302 b in the sleeve 174. Further, the distal end ofthe endoscope shaft 126 includes an elastomeric sleeve 310 thatsurrounds the angled transition sleeve section 186, the distal tipsection 185 as well as a distal portion 312 of the proximal straightsleeve section 180 (FIG. 7B). Thus, as can be seen in FIG. 7A, theelastomeric sleeve 310 has sufficient elastic strength to collapse orconstrict the working channel portion 170′ to the smaller cross-sectionas seen in FIG. 7A.

As can be seen in FIG. 7A, the lower sleeve portion 296 includes asleeve wall 315 with sufficient curvature to maintain an open pathwaythrough the distal working channel portion 170′ when the elastomericsleeve 310 constricts the distal channel portion 170′ which therebyalways provides an open fluid outflow pathway. For example, the sleevewall 315 can have a curvature representing the same diameter as aproximal portion of sleeve 174 and extend over a radial angle rangingfrom 30° to 90°. While the lower sleeve portion 296 shown in FIG. 7Acomprises a portion of the wall of metal sleeve 174, in anothervariation, the flexible lower sleeve portion 296 may be any bendableplastic material or a combination of plastic and metal.

FIG. 7B next shows the distal working channel portion 170′ in its secondexpanded configuration as when a physician inserts an elongated tool 188(phantom view) through the working channel 170. Such a tool 188 willinitially slide along the hinge portion 298 of the lower sleeve portion296 and then stretch the elastomeric sleeve 310 to open distal workingchannel portion 170′ to allow the tool 188 to extend through the workingchannel. In other words, the elastomeric sleeve 310 will be stretched ordeformed to a tensioned position as shown in FIG. 7B as a tool isinserted through the distal working channel portion 170′. When the tool188 is withdrawn from the working channel portion 170′, the elastomericsleeve 310 will return from the tensioned position of FIG. 7B to therepose or non-tensioned position of FIG. 7A to return the workingchannel portion 170′ to the constricted configuration FIG. 7A.

In general, the endoscope component 125 corresponding to the inventionallows for the use of an image sensor 128 having a large diagonaldimension relative to the insertion profile or diameter of the endoscopeshaft 126 while at the same time providing a working channel 170 thathas a large working channel diameter WCD relative to the insertionprofile or diameter of the endoscope shaft assembly 126. More inparticular, the endoscope component 125 comprises endoscope shaft 126having a shaft diameter SD extending to a distal sleeve section 185, animage sensor 128 with a diagonal dimension DD carried by the distalsleeve section 185 and a working channel 170 having a diameter WCDextending through the elongated shaft 126, wherein the working channelportion 170′ in the distal end of the shaft 126 is adjustable in shapeto accommodate a tool 188 introduced therethrough and wherein thecombination or the sensor's diagonal dimension DD and the workingchannel diameter WCD is greater than the shaft diameter SD (see FIG.7A).

In a variation, the sensor diagonal dimension DD is greater than 50% ofthe shaft diameter SD or greater than 60% of the shaft diameter. In avariation, the working channel diameter WCD is greater than 30% of theshaft diameter, greater than 40% of the shaft diameter or greater than50% of the shaft diameter. In other words, the working channel portion170′ in the distal end is adjustable between a first cross-sectionaldimension and a second cross-section dimension. In the variation ofFIGS. 7A-7B, the working channel portion 170′ in the distal region ofthe endoscope shaft 126 is adjustable between a partially constrictedshape and a non-constricted shape.

In one variation, referring to FIG. 7A, the distal tip section 185 ofthe endoscope shaft 126 has an axial dimension D1 ranging from 5 mm to20 mm. Also referring to FIG. 7A, the angled transition sleeve section186 extends over a similar axial dimension D2 ranging from 5 mm to 20mm. Still referring to FIG. 7A, the central axis 182 of distal tipsection 185 can be parallel to and offset from the longitudinal axis 175of the straight shaft section 180 by a distance ranging from 1 mm to 10mm.

Now turning to FIG. 8, the image sensor 128 is carried in a sensorhousing 340 that also carries a lens assembly 345 as is known in theart. In one variation, the housing 340 also carries one or more lightemitters, in the variation shown in FIGS. 7A and 7B, two LEDs indicatedat 260 are shown carried in opposing sides of the sensor housing 340. Ofparticular interest, the distalmost surface 350 of the lens assembly 345and the LEDs 260 are disposed distally outward from the distal surface352 of distal tip section 185 as shown in FIG. 8. It has been found thatproviding such a distalmost surface 350 of the lens assembly and theLEDs outwardly from the distal surface 352 of distal tip section 185improves lighting from the LEDs 260 as well as improving the field ofview of the image sensor 128. The distance indicated at D3 in FIG. 7 canrange from 0.2 mm to 2.0 mm.

Now referring to FIG. 7A, another aspect of the invention comprises anoptionally dedicated fluid pressure sensing channel 360 that extendsthrough a thin wall sleeve (not shown) in the endoscope shaft 126. Ascan be seen in FIG. 7A, the distal end of the pressure sensing channel360 is open in the distal surface 352 of the endoscope shaft 126. Thepressure sensing channel 360 can extend to disposable pressure sensor inthe handle housing 145 (not shown). Such a disposable pressure sensorthen can have electrical leads coupled through the electrical connector190A in the handle housing 145 thereby send electrical signalsindicating pressure to the controller 110A (FIG. 1). Thus, in oneaspect, the disposable endoscope component 125 carries a single-usepressure sensor coupled by a detachable connector to a remote controller110A.

In one variation of a pressure sensing mechanism, referring to FIG. 7A,the wall of the pressure sensing channel 360 consist of a hydrophobicmaterial, which can be any suitable polymer such as PFTE, having aninterior diameter ranging from 0.25 mm to 2.5 mm. Often, the diameter ofchannel 360 is between 0.5 mm and 1.5 mm. It has been found that ahydrophobic surface in a pressure sensing channel 360 will prevent themigration of fluid into the channel and thereby trap an air column inthe channel communicating with the pressure sensor. The compressibilityof the air column in the pressure sensing channel 360 is notsignificantly affect the sensed pressure since the channel diameter isvery small. In another variation, a metal sleeve can be coated with ahydrophobic surface or an ultrahydrophobic surface.

Now referring to FIGS. 1, 2 and 4, it can be seen that the handlecomponent 120 has an angled pistol grip portion 192 with an axis 194that is angled from 10° to 90° away from the axis 175 of the endoscopeshaft 126. The grip portion 192 includes a finger or thumb-actuatedcontrol pad 122 that carries actuator buttons for operating all thefunctions of the treatment system, for example, including (i) operatingthe fluid management system 105, (ii) capturing images or videos fromsensor 128, (iii) adjusting light intensity from the LEDs 260, etc. Asdescribed above, the control unit 108 typically carries the imageprocessor 110B. However, the interior of the handle component 120 alsocould carry the image processor 110B or a processing component thereof.

FIG. 4 illustrated the handle component 120 and endoscope component 125from a different angle where it can be seen that the grip portion 192has a recessed channel 385 therein that is adapted to receive and lockin place the inflow and outflow tubing, 200A and 200B, so as tointegrate the tubing set with the pistol grip 192 during use. Thisfeature is important so that the inflow and outflow tubing will notinterfere with operation of the endoscope component 125 or a toolintroduced through the working channel 170. The pistol grip 192 can havea single recessed channel 385 to receive both the inflow and outflowtubing or two recessed channels for separately receiving the inflowtubing and the outflow tubing.

Now turning to FIG. 6, the enlarged view of the assembled handlecomponent 120 and endoscope component 125 shows the control pad 122 withfour actuator buttons or switches which are adapted to operate thesystem. In one variation, actuator 402 is adapted for turning on and offirrigation, or in other words actuating the fluid management system 105to provide fluid inflow and fluid outflows. Actuator 404 is adapted forimage or video capture. In a variation, momentary pressing the actuator404 will capture a single image and longer pressure on the actuator willoperate a video recording.

The actuator or scrolling button 406 has a scrolling function, whereinpressing the scrolling button 406 will cycle through various subsystems,wherein each subsystem then can be further adjusted by the centralbutton or up/down actuator 410, which is adapted for increasing,decreasing or otherwise changing an operating parameter of any selectedsubsystem. In one example, the scrolling button 406 can be actuated tocycle through the following subsystems and features: (i) fluidinflow/outflow rate from the fluid management system 105; (ii) the setpressure which is to be maintained by fluid management system 105; (iii)fluid deficit alarm which is calculated by the fluid management system105; (iv) optional selection of still image capture or video capture,and (v) LED light intensity. Then, after scrolling to select asubsystem, the physician can actuate the central up/down actuator 410 toadjust an operating parameter of the selected subsystem. As will bedescribed further below, the selection of subsystems as well as thereal-time operating parameters of each subsystem will be displayed on avideo monitor or display 112 as shown in FIG. 1. Thus, it can beunderstood that the physician may operate the scrolling button 406 toscroll through and select any subsystem or feature while observing suchas selection on the display 112, and then actuate the up/down actuator410 to adjust an operating parameter which also can be observed on thedisplay 112.

In another aspect of the invention, the controller 110A includes acontrol algorithm for operating the control pad 122 which provides ajump back to a default condition after the scroll button or actuator 406has been used by the physician. For example, the default condition willbe a selected default subsystem which is actuatable by the centralup/down actuator 410. In one variation, the default subsystem is thefluid inflow/outflow rate, which may be the subsystem most commonlyactuated by the physician to control fluid flow into and out of aworking space. As described above, the physician may use the scrollingbutton 406 to select any subsystem for adjustment of an operatingparameter. If, however, the physician does not continue to scrollbetween the various subsystems or change a parameter within apredetermined time interval, then the control algorithm will jump backto the default subsystem, which may be the fluid inflow/outflow rate.The predetermined time interval, or timeout, for the control algorithmto jump back to the default condition may be anywhere from 1 second to10 seconds, more often between 2 seconds and 5 seconds.

Still referring to FIG. 6, the assembly of the handle component 120 withendoscope component 125 is shown with a plane P to illustrate thesterile field 415 and the non-sterile field 420 relative to theendoscope assembly. As can be understood, the disposable endoscopecomponent 125 is sterilized and the physician or nurse would remove thecomponent 125 from sterile packaging which would then define a sterilefield 415. The endoscope component 125 then would be mated with thehandle component 120 which defines the non-sterile field 420. In othervariations (not shown), a plastic film or other plastic housing couldcover the handle portion 120.

A method of the invention can also be understood from FIG. 6. It can beunderstood that the physician must insert the tool 188 into the workingchannel 170 in a manner that would insure the sterility of the tool. Ascan be seen in FIG. 6, the grip 152 which is sterile has a largediameter recess R therein which tapers into the proximal port 172 of theworking channel 170. In one variation, the diameter of the recess R isat least 15 mm and often greater than 20 mm. The depth of the recess canrange from 5 mm to 20 mm or more. Thus, it can be understood that thephysician can easily insert the distal end 425 of a tool 188 into themouth of the large diameter recess R without any risk of contacting thenon-sterile handle portion 120. Thereafter, the physician can move thetool distal end 425 distally over the surface 428 of the recess R andinto and through the port 172 of the working channel 170. By using thismethod, the physician can be assured that the tool 188 will not contactthe non-sterile field 420.

Now turning to FIG. 9, another aspect of the invention is shown whichrelates to electronic mechanisms carried by the endoscope 500 forre-orienting the image on the display in response to rotation of theendoscope shaft 510 to ultimately provide an image-upright configurationon the display. In one variation, an accelerometer 515 (which cancomprise an accelerometer gyroscope combination) is provided which cansend signals to a controller and image processor related to rotation ofthe endoscope shaft 510. For example, an STmicro IIS2DH 3-axisaccelerometer can be used or a 6-axis IMU (Inertial Motion Unit) with3-accelerometer and 3-gyroscope axis such as an STmicro ISM330DLC can beused.

The image processor in the controller then can use the accelerometersignals to calculate a necessary amount of rotational correction for theimage re-orientation. The calculation includes the degree of rotation ofthe shaft 510 relative to the longitudinal axis 518 of the shaft 510.The image is then electronically rotated to display on any video displayor monitor can be carried by the handle of the device or most often is aremote display. Thus, the video image on the display can at all times bein an image-upright configuration for viewing by the physician.

As can be seen in FIG. 9, the accelerometer 515 is carried on theproximal spool 285 which is rotatable within the handle assembly 520.Thus, any rotation of the rotating component 522 independent of thehandle 524 or rotation of the handle 524 relative to the longitudinalaxis 518 of the shaft will be sensed by the accelerometer 515 to thusallow reorientation of the image on the display. In the variation ofFIG. 9, a second accelerometer 540 is carried on the circuit board 545which is fixed in the non-rotating handle 524. Thus, signals from thisaccelerometer 540 provide signals of rotation of the handle only. In onevariation, signals from both accelerometers 515, 540 can be compared todetermine rotation of the rotating component relative to the handle 524.In one aspect, signals from the second accelerometer 540 can be used ifsignals from the first accelerometer 515 fail for any reason. An alerton the display can indicate to the user if either the first or secondaccelerometer has failed to perform properly.

FIGS. 10 and 11 illustrate another variation of an endoscope working end550 which is similar to the previous embodiment. The thin-wall outersleeve 552 is in phantom view in FIG. 10 and the thin-wall workingchannel sleeve 554 is shown. As described previously, electronic signalsfrom the image sensor 555 (FIG. 11) as well as power for the imagesensor and LEDs 558A and 558B are carried in a flex circuit 560extending through the shaft 510 of the endoscope. Since the endoscopeshaft 510 will be operating in a fluid environment, it has been foundthat significant RF shielding is needed around the signal-carryingelectrical conductors in the flex circuit 560 to ensure that potentialelectrical devices introduced through the working channel 564 will notgenerate electrical fields that may interfere with signals carried inthe flex circuit 560.

Thus, in one variation shown in FIG. 10, the flex circuit may be anedge-coupled stripline design where two outer dielectric layers 562 aand 562 b carry electrical conductors 565 (including ground planes) andare configured to function as a shield relative to the electricconductors 570 disposed in a middle layer 572 between the two outerlayers 562 a and 562 b. In this variation, the plurality of electricconductors 570 disposed in the middle layer 572 are adapted to carry allthe signals from the image sensor 555. Thus, the two outer layers 562 aand 562 b function as a shield to prevent any potential interferencefrom electrical tools that might interfere with the signals carried bythe interior conductors 570 in the middle layer 572.

In one variation, the signal carrying conductors 570 in the middle layer572 are provided with a dielectric insulator layer on both sides thathas a thickness of at least 0.0005″, at least 0.001″ or at least 0.002″.The insulator layers can be any suitable power material such Kapton.

In some variations, the number of electrical conductors 570 that carryimage signals in the middle layer 772 can vary from 4 to 24 or more andtypically range from 12 to 20 conductors. In this variation, theelectrical leads to the LEDs 558A and 558B are also carried in themiddle layer 572 which could be subject to interference from electricaltool. Thus, providing the electrical leads and signal conductors in themiddle layer 572 in the stripline design allows for an overall flexcircuit 560 that is thinner and more flexible than other configurationsthat provide adequate RF shielding.

Now turning to FIGS. 11-13, the endoscope shaft working end 550 issimilar to that of FIGS. 7A and 7B. In the variation of FIG. 11, theshaft working 550 end has a secondary flexible hinge portion 580 whichallows for changing the angle of the field of view FOV of the imagesensor 555 about its axis 572. For introduction into a working site inthe patient's body, the working end 550 of the shaft 510 has a distalsegment 585 that has an axis 588 that is angled relative to thelongitudinal axis 590 of the shaft 510 at a selected angle which can befrom 5° to 30°. It can be seen in FIG. 11 that a second or intermediatesegment 595 of the working end 550 includes a living hinge portion 580which allows it to flex relative to the proximal shaft segment 600. Theintermediate segment 595 and distal segment 585 are fixed together at anangle which can be seen in FIGS. 11 and 12A. The mechanism for actuatingthe distal segment 585 and intermediate segment 595 to a flexed position(see FIG. 12B) consists of inserting an elongated tool body or shaft 604through the working channel 564 as described previously.

FIGS. 12A and 12B are schematic transparent views of the working end 550of FIG. 11 showing the interior working channel 564 and the proximalshaft segment 600, the intermediate shaft segment 595 and the distalshaft segment 585. In FIG. 12 B, it can be seen that the elongated toolbody 604 (phantom view) has been inserted through the working channel564 which causes multiple effects. First, as described previously, theelongated tool shaft 604 stretches the resilient silicone sleeve 610around the working end 550 (FIG. 11) to expand the working channel 564from a collapsed condition to an expanded condition. At the same time,the introduction of the tool shaft 604 through the working channel 564flexes the proximal hinge 580 at the proximal end of the intermediatesegment 595 to cause the intermediate and distal segments 595 and 585 toflex away from the repose position (FIG. 12A) to a tensioned position(FIG. 12B) wherein the axis 588 of the image sensor 555 is parallel tothe longitudinal axis 518 of the proximal shaft portion 600. In thisflexed position of FIG. 12B, the image sensor 555 then is aligned withthe longitudinal axis 518 of the shaft and the sensor axis 572 and theangle of the field of view FOV then can be 0° relative to thelongitudinal axis 518 of the shaft.

In this variation shown in FIG. 11, it can be seen that the tensioningsupport sleeve 625 is shown which partially surrounds the proximalendoscope shaft portion 600 and sleeve segment 595. More in particular,the support sleeve 625 has an upper surface 628 that is fixed to theadjacent upper surface 630 of the proximal shaft portion 600. Thesupport sleeve 625 has a longitudinal discontinuity 626 therein and thesleeve extends around the shaft from about 200° to 360°. It can furtherbe seen in FIG. 11 that the support sleeve with a length LL whichextends over a portion of the proximal shaft 600 and over a portion ofthe intermediate sleeve 595. As can be seen in FIGS. 11 and 13, theinterior portion of the support sleeve 625 has the longitudinal gap ordiscontinuity 626 which allows the side portions 640 a and 640 b to beflexed outwardly when an elongated tool shaft 604 is introduced throughthe working channel 564. In this aspect, the support sleeve 625functions as a spring which urges the support sleeve 625 radiallyinwardly to return the endoscope shaft 510 to a straight configurationwhen the tool shaft 604 is removed from the working channel 564.

In another aspect of the invention referring to the exploded view ofFIG. 13, it can be seen that the distal end of the distal shaft segment595 includes a housing 650 that carries both the image sensor 555 andfirst and second LEDs 558A and 558B. The housing 650 can be molded outof any suitable polymer and includes means for providing flex circuitconnections to both the image sensor 555 and the LEDs. An upper guidesurface 655 is coupled to the sensor housing 650 to provide a slidinginterface against which the tool shaft 604 can push and deflect thedistal segment 585 and sensor housing 650. A lower guide surface 660 iscoupled by a flexible element 664 to the working channel sleeve 554 toprovide a sliding interface against which the tool shaft 604 can openthe working channel 564 without contacting the silicone sleeve 610 (seeFIG. 11).

Now turning to FIGS. 14 through 17B, another variation of components ofan endoscope working end 700 is shown which includes a distal housing704 that carries an image sensor 705 (FIG. 17B) and lens stack 708together with a flex circuit 710 that is configured for coupling to theimage sensor as well as two LEDs 715A and 715B. In one aspect of theinvention, the elongated flex circuit 710 is adapted to be carried inthe interior of the endoscope shaft or sleeve 720 in a channel that canbe used for fluid inflows and fluid outflows. Thus, the flex circuit 710and its connections to the image sensor and LEDs are entirely insulatedto allow for its use when submerged in such fluid flows.

As can be understood with reference to FIGS. 3A-3B, 5, 10, 12A-12B and13, previous variations of the endoscope of the invention are shown witha flat flex circuit extending through a fluid flow channel in theelongated shaft of the endoscope. It has been found that typicalinsulator layers on flex circuits are suited for operating in an airenvironment where electrical coupling through the surface insulator isnot problematic. However, it has been found to be challenging when sucha flex circuit carries sensitive conductors from an image sensor andwhen the flex circuit is submerged in a fluid environment and inparticular in a conductive saline fluid inflow or outflow. The endoscopeof the present invention includes an integrated fluid management systemand therefore the flex circuit has to be effectively insulated toprevent noise in the image sensor conductors.

Referring to FIG. 15, the first or superior insulator layer 725A and thelast or inferior insulator layer 725E the of the flex circuit 710comprise dielectric layers that are thick enough to prevent capacitivecoupling therethrough to the image sensor conductors indicated at 742 inFIG. 15. In one variation, the superior and inferior dielectric layers725A and 275E each comprise a polymeric layer having a thickness of atleast 0.002″. In other variations, the dielectric layers each are atleast 0.003″ or at least 0.004″. In one variation, the dielectric layercan be a polyamide such as Kapton®. In general, a flexible circuit foran endoscope used in a fluid environment corresponding to the inventioncomprises an elongate flexible circuit extending in a planar shape to adistal end, an image sensor operatively coupled to a surface of the flexcircuit with a first arrangement of electrical conductors therein, anillumination source operatively coupled to a surface of the flex circuitwith second arrangement of electrical conductors therein, where saidfirst arrangement of electrical conductors is disposed in an interior ofthe flex circuit with superior and inferior dielectric layers sufficientto prevent electrical coupling through said dielectric layers to therebyprevent interference with image sensor signals carried by said firstarrangement of electrical conductors. FIG. 14 is perspective view of thehousing 704 and lens assembly or stack 708 in the distal working end 700of an endoscope similar to that of FIGS. 10, 11, 12A and 12B. It can beseen that a single flex circuit 710 is shaped for folding to allow theimage sensor 705 and the LEDs 715A, 715B to be oriented distally oraligned with the longitudinal axis 722 of the endoscope shaft. Thus, themultiple electrical leads to the image sensor 705 and to two LEDs can beprovided in a single flex circuit which conserves space in the endoscopeshaft which is critically important.

FIG. 15 is perspective view of the distal portion of the flex circuit710 of FIG. 14 in an exploded view showing the five thin film layersthat comprise of the flex circuit 710 in a planar form before bondinginto the single component. The first layer 725A or layer 1 comprises athin-film insulator layer which covers the electrical leads in thesecond layer 725B or layer 2. A central portion of the distal end of thelayer 1 indicted at 725A includes an open port 728 that exposes theelectrical leads in layer 2 (725B) for coupling to the image sensor 705as shown in FIG. 17A. It can be seen in FIG. 15 that layers 1 through 4of the flex circuit 710 are configured with first and second legs 730Aand 730B that extend laterally or perpendicular to the axis 732 of theflex circuit which are adapted to couple to the LEDs as will bedescribed below.

The second layer 725B or layer 2 of the flex circuit carries a pluralityof electrical leads 735 that extend to the image sensor 705. Layer 3indicated at 725C of the flex circuit carries a planar ground element740. Layer 4 indicated at 725D of the flex circuit carries additionalelectrical leads 742 coupled to the image sensor 705 as well as leadsthat couple the two LEDs in a series connection. Layer 5 indicated at725E of the flex circuit 710 does not have a shape withlaterally-extending legs 730A and 730B corresponding to the shape of thelayers 1 through 4. Layer 5 is configured as a stiffener layer with adistal end 748 that defines a bending region 750 extending transverselyacross the flex circuit 710 to provide a bending line for layers 1through 4 when bonded together (FIGS. 17A-17B).

In FIG. 15, it can be seen that layers 1 through 4 (725A-725D) includenotch features for inducing bending of the flex circuit at selectedlocations. More in particular, notch features 755 provided on eitherside of the flex circuit 710 define a transverse line to induce bendingof the flex circuit perpendicular to the longitudinal axis 732 as can beseen in FIGS. 17A and 17B. The laterally-extending legs or segments 730Aand 730B also include notches 758 which are adapted to induce bending ofsuch laterally-extending segments as also can be seen in FIGS. 17A and17B.

FIG. 16 shows the proximal ends of layers 1 through 4 (725A′-725D′) ofthe flex circuit 710 in an exploded view with layer 1 (725A′) having anopen port 760 to expose the electrical connection points 762 in layer 2(725B′) which are adapted for coupling to a circuit board in theendoscope handle (not shown).

FIG. 17A is perspective view of the distal portion of the flex circuit710 of FIG. 15 showing the image sensor 705 and the LEDs 715A, 715Bcoupled to the flex circuit. In addition, it can be seen that thelaterally-extending segments 730A and 730B are folded 90° away from theplanar shape of the flex circuit as in its manufactured form shown inFIG. 15. The axis 765 of the field of view (FOV) of the image sensor isalso shown. FIG. 17B then shows the transverse bending of the flexcircuit 710 which then orients the axis 765 of the image sensor's fieldof view and the light transmission axes 770 of the LEDs in the distaldirection. Thus, FIG. 17B is a schematic view of the components in theworking end 700 of FIG. 14 where FIG. 17B does not show the lens housing704 or the lens stack 708 with the outer sleeve 720 in phantom view.Referring to FIG. 14, it should be appreciated that the outer or distaltips 780 of the laterally extending segments 730A and 730B can be foldedinwardly at point 782 (FIGS. 14 and 15) to attach to the proximalsurface of the LEDs 715A, 715B or can be adapted to couple to the sideof the LEDs or a circuit component attached to the LEDS as in FIGS. 17Aand 17B.

In general, a flex circuit for an endoscope corresponding to theinvention comprises an elongated flexible circuit manufactured to extendin a planar shape to a distal end having first and second flex elementsadapted to bend away from the planar shape, an image sensor having afield of view (FOV) axis operatively coupled to a surface of the firstflex element, and an LED with a light axis operatively coupled to asurface of the second flex element, wherein the first and second flexelements are capable of bending away from the planar shape to anon-planar shape for coupling to an endoscope shaft or housing where theFOV axis and light axis are in a distal-facing orientation afterbending. It is understood that variations can employ any illuminationsource in addition to, replacing, the LED.

In another aspect, a flexible circuit assembly of the inventioncomprises an elongated flexible circuit member, an image sensor and atleast one LED coupled to a distal portion of the flexible circuit memberin a first spaced apart configuration, wherein said distal portion isconfigured for deformation or folding to dispose the image sensor andthe at least one LED in a second spaced apart configuration for couplingto a distal housing of an elongated endoscope shaft that carries a lensor lens stack for the image sensor.

In another aspect a flexible circuit of the invention comprises anelongated flat flexible circuit member extending in a plane from aproximal end to a distal end and an image sensor operatively coupled toa first surface of the flexible circuit member where the sensor field ofview is orthogonal to said first surface wherein a distal portion of theflexible circuit member carrying the image sensor is configured forflexing away from said plane for coupling to a distal portion of anelongated endoscope shaft to thereby re-orient the sensor field of viewat an angle relative to the plane of the flex circuit member.

FIGS. 18A-18B illustrate another aspect of the invention which comprisesa view of an endoscope video image 800 on a video display or screen 805and a warning indicator or visual alert mechanism. As can be seen inFIG. 18A, a working space 806 with a body lumen 807 and a grasper 808are within the field of view of the endoscope. Typically, the videoimage 800 is shown on a rectangular display or screen 805 where theactual image of the patient's body as seen by the endoscope is shown ina circular form or format 810 surrounded by a blank background 812.

In many endoscopic viewing systems, the video screen 805 also displaystext corresponding to several operating parameters of the system.Typically, such operating parameters are shown in text on a portion ofthe screen outside in the background area 812 outside of the centralcircular image format 810 of the working space 806. As an example, theoperating parameters can include the fluid pressure in the working space806, fluid flow rate into or out of the working space, fluid volumeremaining in the fluid source such as a saline bag, the length of timethe procedure, fluid intravasation in the patient, and signal orwarnings of other operating parameters known in the art.

During a procedure, the physician often will be concentrating on thecentral circular image 810 to closely observe manipulation of tools inthe working space 806. The physician may not see or be able to monitorthe text on the side of the video display that is outside the circularimage 810 of the working space.

FIG. 18B shows the video display or screen 805 of FIG. 18A andillustrates another aspect of the invention. In this variation, anoperating parameter of the system is indicated as a colored region orindicator region 820 adjacent to the circular image 810 of the workingspace 806. In one variation, the indicator region 820 can be an annularband (or the entire peripheral display area of the screen) of anysuitable color such as red, blue, yellow, etc. This annular indicatorregion 820 will immediately capture the attention of the physician whenviewing the working space. The colors used in the indicator region 820also can be selected to indicate which operating parameter is beinghighlighted to thereby further inform the physician. Alternatively, theindicator region 820 can have a first color such as yellow to indicate aless significant warning, and a second color such as red to indicatethat immediate action by the physician it is required.

FIGS. 19A-19C show another variation of an indicator region 822 were inthe width of the indicator region, for example the width W of theannular band, also can vary in width W. FIG. 19A shows the video screenwithout the in the annular indicator region. FIG. 19B shows theindicator region 822 with a first width W and FIG. 19C shows the annularindicator greater with a second wider width W′. The width also may pulseat a slow interval or a fast interval between different widths tocapture the attention of the physician.

FIGS. 20A-20C indicate another variation of an indicator region 824wherein colored portions of a part annular band are shown which canrotate at various speeds. FIG. 20A shows the endoscopic image without awarning region. FIGS. 20B and 20C show rotation of the part annularcolored region 824. In this variation, the colors again can pulse inintensity or switch between different colors and at slow or fast rate toprovide an effective alert to the physician.

Now referring to FIG. 21, another aspect of the invention relates tooptimizing quality of the images displayed on the video display 805 byenhancing the refresh rate on pixels in the video display. In FIG. 21,it can be seen that the central endoscopic image 840 is surrounded bybackground 845 within the video display 805, each of which can bedefined by the number of pixels on the screen. For example, the centralimage 840 can comprise 50% of the total pixels on the screen and thebackground 845 can comprise the remaining 50% of the pixels on the videodisplay 805. In normal operation, the signal processor is capable of arefresh rate across the entire video display, for example, having arefresh rate of 30 Hz, 60 Hz or a multiple thereof. According to anaspect invention, the software that controls image processing anddisplay can be adapted to block any refreshing of the pixels in thebackground 845 and only refresh the pixels in the central image 840. Inthis example, the refresh rate then can be effectively doubled whichwill result in a higher quality image for any given refresh rate of theimage processing system.

In general. a method of the invention for enhancing video image qualityin an endoscopic viewing system comprising providing an endoscopicviewing system including an image sensor, an image processing system,and a video display having a fixed number of pixels, displaying videoimages in a circular central portion of the display thereby utilizing afirst fraction of the pixels, wherein pixels in a peripheral portion ofthe display outside the central portion are not utilized, andconfiguring the image processing system for refreshing the pixels in thecentral portion and to block refreshing of the pixels in the peripheralportion to thereby enhance the refresh rate of the central portion andimprove image quality.

In another aspect of the invention, the image processing system andaccelerometers used in orienting and stabilizing an endoscopic image ona video display are adapted to filter out high-frequency vibrationscaused by operating components that can affect image signals and thequality of the image on the display. FIG. 22 shows a working end 860 ofthe tubular cutter or resecting probe 865 of the type known in the artand adapted for insertion through the working channel of the endoscopeof the invention (see FIGS. 10-13). The resecting probe 865 of FIG. 22is adapted for detachable coupling to a motor drive handpiece as isknown in the art.

In prior art endoscope systems and image processing software, it hasbeen known to filter and a user's hand movements from the imagingsignals to stabilize and improve image quality. Such hand and fingermovements are known to have a maximum repetition rate of movement of 3Hz. In the present invention, the resecting probe 865 of FIG. 22 and themotor drive coupled thereto will rotate the inner cutting sleeve atrates of 500 RPM to 15,000 RPM. Such high speeds will cause significantvibrations and harmonics thereof that are far higher than movementscaused by a user's hand movements. Therefore, it has been found that itis necessary to filter out many specific higher frequencies and/oramplitudes that otherwise would cause noise in the system and therebyprovide signal conditioning that would not be needed in typicalendoscopes.

Thus, the system and method of the invention includes softwarealgorithms and components that allow for filtering noise vibrations thatoccur at greater than 3 Hz. The system filters out vibrations ormovements of greater than 5 Hz, greater than 10 Hz, or greater than 50Hz. Such signal conditioning will provide a stable and suitable highquality video image on the video display.

In another aspect of the invention, referring to FIG. 22B, it can beseen that working end has an rotating inner sleeve 866 and inner cuttingwindow 868 that rotates in outer sleeve 870 and outer sleeve cuttingwindow 872 to resect tissue as is known in the art. Such a resectionprobe is used in a hysteroscopic procedure to resect polyps andfibroids. Such tissue can vary in size and hardness and the resectingprobe 865 typically may be adapted to operate at a fixed rotational oroscillating speed, for example, 1,000 RPM, 3,000 RPM 5,000 RPM or more.It has been found that for cutting fibroids of differing hardness, thefixed cutting speed may be relevant to the rate of tissue removal, butit is equally or more important to control the aspiration rate of fluidthrough the cutting windows 868 and 872 during use. As can be understoodconceptually, when the target tissue is soft, such soft tissue is easilysuctioned into and captured within the cutting windows. However, densetissue cannot be suctioned into the cutting windows 868, 872 aseffectively which results in a slower rate of tissue removal. Therefore,it has been found that the tissue resection rate can be improved foreach hardness of tissue by varying the fluid outflow rate which providesa selected level of suction in the cutting windows. The system thus isconfigured with a selector for selecting between two or more fluid flowrates. The fluid flow rate for soft tissue apart to low, the fluid flowrate for hard tissues is higher. In one variation, the physician isallowed to select fluid flow rate from 100-250 mL/min for soft tissue,250-500 mL/min for medium hardness tissues and 500-1,000 mL/min for hardtissues.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. A method for displaying alerts together with images captured by an image sensor on a display device, the method comprising: providing an integrated diagnostic and therapeutic system that includes an in vivo imaging component, a fluid management component and a controller configured to control operating parameters of the in vivo imaging component and the fluid management component; displaying images captured by the image sensor as a video in a first central display area of a display device; and displaying visual alerts of selected operating parameters provided by the controller in a second peripheral display area of the display device.
 2. The method of claim 1, wherein the second peripheral display area comprises an annular band around the first central display area.
 3. The method of claim 2, wherein the second peripheral display area comprises an at least partial annular band around the first central display area.
 4. The method of claim 3, wherein the annular band is adapted to change dimensions over a time interval.
 5. The method of claim 4, wherein the dimensions are adapted to change in at least one of in a radial dimension and a radial angle dimension.
 6. The method of claim 5, wherein the annular band has more than one color.
 7. The method of claim 6, wherein the annular band is adapted to rotate over a time interval.
 8. The method of claim 7, wherein the annular band is configured to flash ON and OFF over a selected time interval.
 9. A method for providing enhanced video image quality in an endoscopic viewing system, the method comprising: providing an endoscopic viewing system including an image sensor, an image processing system, and a video display having a fixed number of pixels; displaying video images in a circular central portion of the video display thereby utilizing a first fraction of the fixed number of pixels, wherein a second fraction of the fixed number of pixels are located in a peripheral portion of the video display outside the circular central portion and are not utilized; and configuring the image processing system for refreshing the pixels in the circular central portion and to block refreshing of the pixels in the peripheral portion to thereby enhance the refresh rate of the circular central portion and improve image quality. 